Welcome, ladies and gentlemen, and welcome to the 2024 AGM for Race Oncology Limited. My name is Peter Smith, Executive Chair, and I'll be chairing today's meeting. It's now 12:00 P.M., and we have a quorum of shareholders present, and I declare the meeting open for business, and I confirm the meeting has been properly constituted. Today's meeting has been convened in accordance with the Corporations Act. I'd like to introduce our Board of Directors and Management Team who are present at the meeting today. In fact, I think we've got the entire team with us today. Firstly, I'd like to welcome my fellow board members, Dr. Daniel Tillett, Managing Director and CEO of Race, and Serge Scrofani, Non-Executive Director, and I'd like to welcome our Company Secretary, Mr. Peter Webse, sitting down here in front of me. I'd also like to welcome members of our Management Team, including Dr.
Michelle Rochford, our Chief Medical Officer, Dr. Sophia Moscovis, Vice President of Operations and Strategy, Mr. Brendan Brown, who's our Chief Financial Officer, Professor Mike Kelso, who is Vice President of Research, and Dr. Marinella Messina, Vice President of Clinical Development. I'd also like to mention that we've got the rest of the team: Peter Kapitein, Emily Ryan, Feroz Ahmed, Rodney Cusack, Michelle Hwa, and Sharon Sampey, so welcome to all of you as well. Finally, I'd like to introduce Mr. Doug Bell, who's representing the company auditor, Hall Chadwick, who is attending the meeting online, so the agenda, pretty short agenda, my address, and then we'll go to the formal business of the meeting and then on to the CEO presentation.
Turning to this past financial year, it has been one of important progress for Race as we move closer to taking our new formulation of bisantrene RC220 into patients for the first time, building on our past successes with bisantrene. This steadfast focus on advancing RC220 to clinics saw us achieve several significant milestones during the year. These included completing manufacturing to good manufacturing practice, or GMP standards, the RC220, concluding our required toxicology and safety pharmacology studies conducted under good laboratory practice, or GLP standards, as well as selecting our contract research organization, George Clinical, to support our upcoming phase IIa/IIb trial of RC220. Each of these activities required a huge effort from the entire Race Team, and they're all extremely significant in their own right. And this sets us up strongly for the next stage of our RC220 clinical program.
All this work has been conducted at a standard beyond that required to conduct a phase I study in Australia and will enable the same data to be used to support an investigational new drug application, or IND, in the U.S. next year. Although we don't need to file an IND to support the phase I study in Australia, it will give us the flexibility to support trials in the United States, as well as sending a very, very strong quality signal to any potential partners, be they based in the U.S. or elsewhere. We continued our board renewal process and in September announced the retirement of Mary Harney as Non-Executive Chair and Phil Lynch as Non-Executive Director. We owe a great deal to them and a great deal of gratitude to them for their meaningful tenures at Race.
The company grew and strengthened substantially through their many years of involvement, and I personally enjoyed working with them both immensely. Following Mary's retirement, I was pleased to step into the position of Executive Chair with my conviction in the company solidified, having served on the board for the previous 15 months. In parallel, Dr. Daniel Tillett moved from Chief Executive Officer to Chief Executive Officer and Managing Director, a reflection of the integral role he plays for Race and of his deep understanding and enthusiasm for the opportunities that bisantrene represents. The other important piece to the board renewal strategy was the employment of Dr. Serge Scrofani as an independent Non-Executive Director. Serge has had a stellar career both academically and in industry, most notably with CSL, where he had senior roles in strategy and business development.
Already in his short time on the board, Serge has made a substantial impact, bringing deep insights in business strategy and commercialization. I look forward to continuing to work closely with Serge in the months ahead as we focus on the significant commercial opportunity ahead of us. In 2024, we focus on strengthening our scientific and clinical advisory boards, and we're delighted to welcome Associate Professor Erin Howden of the Baker Heart and Diabetes Institute. Associate Professor Howden's work on VO2 peak is extremely important given our focus in cardio-oncology. Furthermore, we established strong relationships with some of the key scientists and clinicians who were involved in bisantrene's initial development to help further our understanding of the drug, including distinguished oncologist Professor Daniel Von Hoff, who joined our clinical advisory board.
Professor Von Hoff is exceptionally well known in the industry, having been involved in the clinical development of numerous oncology drugs, including bisantrene, back in the 1980s. His willingness to work with us on RC220 is indicative of his undiminished enthusiasm for the molecule, and he has already made numerous contributions to our thinking and clinical plans. While we were preparing RC220 for the upcoming clinical studies, we announced a series of impressive preclinical results that reinforce the unique properties of bisantrene, owing to its anti-cancer and cardio-protective properties. Preclinical work performed at Oncolines in Holland showed bisantrene's potent cancer-killing activity in 113 out of 143 cancer cell lines, representing all of the major hematological and solid tumors.
When used in combination, bisantrene improved the cancer-killing activities of doxorubicin, an anthracycline chemotherapeutic and one of the most widely used anti-cancer drugs, with more than 20 million doses provided to patients around the world each year and continuing to grow. In a similar study, bisantrene, in combination with decitabine, displayed enhanced cancer-killing ability across the same broad panel of 143 cancer cell lines, another very promising result. Furthermore, additional preclinical work showed that bisantrene, as a single-agent treatment, was found to be effective against human multiple myeloma in a mouse model, which would support further future evaluation of bisantrene and carfilzomib combination as a potentially more effective treatment for multiple myeloma. Always get tripped up by those ones.
We were pleased to announce that the RC110 bisantrene phase Ib, phase II, the investigator-sponsored trial led by Professor Arnon Nagler at the Chaim Sheba Medical Center in Israel, had concluded, having met all of its endpoints. Results showed that 40% of the patients with relapse or refractory acute myeloid leukemia in the phase II efficacy trial responded to RC110 bisantrene in combination with cladribine and fludarabine. Although the study focused on the original RC110 formulation, the results have stimulated further clinician interest in taking the drug forward in new AML trials using RC220. We are still discussing future clinical trials with an Australian investigator in the AML field, and we'll update our shareholders when we receive formal requests for support. I'm incredibly proud of Race Team's accomplishments over the past year.
Their dedication to advancing bisantrene to the next stage remains unwavering, and we're all very, very excited about the journey ahead. The team has worked tirelessly to complete all the regulatory paperwork required for human ethics submission for our RC220 phase Ia/Ib trial in solid tumors. The next step is submission to the first human ethics committee in the near term. This will be a major milestone for all of us. The foundation of all our efforts is the support of prominent medical institutions and respected experts in the field of oncology and cardiology. We remain committed to collaborating closely with them to advance our commercialization objectives. In conclusion, I want to express my gratitude to the entire Race Team for their dedication to driving the company forward.
Having been involved in many companies over the years, I can say that the level of commitment, engagement, and innovation of this team is exceptional, and it's a great pleasure to be working at Race. We are united by a shared mission to make a difference in the lives of cancer patients, wherever they may be, while increasing value for our shareholders. Thank you. Does anyone have any questions now? There will be an opportunity to ask questions at the end of all the presentations, but I'm happy to take any now if you have them. No? Okay. In that case, we'll now move on to the formal part of the meeting. Please slide. Yeah. The motice of meeting was lodged with ASX on 23rd of October 2024.
We will take the notice of meeting and the resolutions to be considered at the meeting as read if there are no objections. Voting on all resolutions will be conducted by a poll. For the purpose of this poll, I appoint Adrian Atkinson of Automic Group, the company's share registry, who has examined and prepared summaries of the proxy forms received to act as returning officer and to conduct the poll. When registering for the meeting, you will have received a yellow voting card if you are either a voting shareholder or proxy holder in attendance, and a blue card if you're a non-voting shareholder. The yellow or blue card should be raised when you wish to ask a question during the discussion on the resolutions.
The yellow voting card will also be used for registering your vote when the poll is called at the conclusion of the consideration of the resolutions. Proxies have been inspected, and all those validly lodged have been accepted. Proxies have been received from 172 shareholders representing 45.6 million shares, being 26.2% of the company's issued capital. I will declare the proxies received on the resolution before putting the resolution to a vote. I would like to highlight that where undirected proxies have been given in favor of the chair, I will be voting those proxies in favor of all resolutions being put to the meeting today. We will now proceed to the resolution set out in the Notice of Annual General Meeting.
The first item of business is to receive and consider the annual financial report of the company for the year ended the 30th of June 2024, together with the declarations of the directors, the director's report, and a remuneration report, and the auditor's report. The financial report and the reports of the directors and the auditor are now laid before the meeting. There will be no vote on this item, and it is for discussion only. The company's auditor for the 2024 financial year, Hall Chadwick WA, is represented by Mr. Doug Bell, who is present electronically to take questions relevant to the conduct of the audit and the preparation and contents of the independent auditor's report. Are there any questions or comments on the financial report or reports to the directors and auditors? Nope, then I'll continue. Are there any questions or comments on the management of the company?
What is the next step after that? Let's assume we get its approval for trialing this drug with humans. Can you give us a couple more steps?
Well, there are certainly some logistic steps in terms of getting everyone in the pharmacy prepared and up to speed, and we're having all of the testing of all the samples and all of that handling. That's all been worked on in the background. So really, the major step after that is recruitment of the first patient.
Right. Back then, would the trial start in this current financial year that we're in now?
We certainly hope to have ethics in. Whether we get the first patient on will depend very, very much on the site itself and how quickly they move and how quickly their ethics committee goes through it.
But certainly, we would hope that we could get a first patient on, but I think we have to recognize that we're getting late in the year now. But it's financially. Oh, financially, yeah. Oh, sorry. Oh, absolutely, yes. Yeah, yeah, definitely.
Thank you.
Yeah, thank you. Any other questions at this point? As I said, there will be plenty of opportunity to ask questions and hopefully get the answers you want at the end of the meeting. So are there any questions relevant to the conduct of the audit and the preparation and content of the auditor's report to be put to the auditor? No? Okay, we will now proceed to the resolutions as set out in the notice of annual general meeting. So resolution one, as set out in the notice of meeting, is to consider as a non-binding resolution the adoption of the remuneration report.
If you wish to discuss this resolution, please raise your yellow or blue card. Okay, the proxy votes received on this resolution are currently displayed on the screen. Voting for this resolution will be conducted by a poll to be held after all the resolutions have been considered. We will now move to the next resolution. Resolution two, as set out in the notice of meeting, is to consider as an ordinary resolution for the election of Director Dr. Serge Scrofani. If you wish to discuss this resolution, please raise your yellow or blue card.
Look, it's been an absolute honor and privilege to have been asked in the first instance to be a board member for Race. I've known Pete for many decades now and obviously been following the story of Race for some time.
I've gotten to know Daniel and the team over the last couple of months, and I'm just so confident and encouraged by what has been done to get the program up to this point. And so moving forward, we're really excited about what the pathway looks like and potentially the commercial options that are available down the track. And that's something that I think that hopefully I can provide some assistance and support over the long term.
What would you like to expand on and what do you read to the board?
Sure. So I was with CSL for 25-odd years and fortunate enough to be in a global role where I had access and exposure to mergers and acquisitions, licensing transactions, business development related, but also really helping guide the strategic overview of the company, both from an organic perspective, what happens internally, as well as inorganic through acquisitions.
And so that, I think, gave me a lot of exposure to what it takes to actually take a product from a nascent idea all the way through to commercialization.
Pleasure.
Yeah, and I can also add that I doubt very much there's anybody with greater experience in commercialization and strategy than Serge. So we are very, very lucky to have him with us. Any other questions, or shall I plow on? I'll plow on. The proxy votes received on this resolution are currently displayed on the screen. And again, voting for this resolution will be conducted by a poll to be held after all resolutions have been considered. We'll now move to the next resolution. As this resolution relates to me, I'll hand the chair over to Serge.
Thanks, Pete.
Resolution three, as set out in the notice of meeting, is to consider as an ordinary resolution the re-election of Director Dr. Pete Smith. If you wish to discuss this resolution, please, please raise your yellow or blue card. Okay. The proxy votes received on this resolution are currently displayed on the screen. Voting for this resolution will be conducted by a poll to be held after all resolutions have been considered. We'll now move on to the next resolution. I'll hand the chair back to Pete.
Thank you, Serge. So resolution four, as set out in the notice of meeting, is to consider as an ordinary resolution the adoption of the Employee Incentive Securities Plan. If you wish to discuss this resolution, please raise your yellow or blue card.
Yes, look, thank you very much.
I have read the note, but could you just briefly explain the scheme and in particular, how far down the chain does the Employee Incentive Scheme go?
Everybody in the company receives incentive options, and it's actually done using a formula that relates to their base salary. So what you'll find, which is actually quite rare, I think, in companies, is that the CEO options, director options, everyone is paid on a ratio to their salary.
This seems like a very strange question from my shareholder. Did I see there was a cap of AUD 8,000 on the bonus in any one year, or have I read incorrectly?
I hope you've read incorrectly. Don't you believe that? No, I think maybe if you can find that number and we can discuss that later, but I'm not familiar with what you're referring to there, unfortunately.
Right. Thank you.
It's okay.
Yeah, but as I said, I think it is actually a very equitably run company. We don't get the CEO with 50 times more options than someone who's toiling away in the lab. That's not appropriate. But back to the resolution. The proxy votes on this resolution are currently displayed on the screen. Voting on this resolution will be conducted by a poll held after all resolutions have been considered, and we'll now move on to the final resolution. I'm sure you're as relieved as I am. Resolution five is set out in the notice of meeting is to consider as an ordinary resolution the issue of director options to Dr. Serge Scrofani. If you wish to discuss this resolution, please raise your yellow or blue card. Okay. The proxy votes received on this resolution are currently displayed on the screen.
Voting for this resolution will be conducted by a poll.
Okay, so on to voting. Ladies and gentlemen, that concludes the resolutions. And as noted, we are conducting a poll on all resolutions. When you registered your attendance for this meeting, voting shareholders and proxy holders were given a yellow voting card. On this card, you will find a series of boxes for voting. For your vote to count, you must tick or mark the corresponding for, against, or abstain box. As a proxy holder, you will have been provided with a report when you registered, which summarizes how you have been directed to vote. When completing this card on the poll, you need only mark a box if you have discretionary votes. If you do not have discretionary votes, then all you need to do is hand your card to the staff collecting the voting cards.
When voting on the resolutions is completed, staff will collect your voting cards. I will now ask you to complete your voting cards for all resolutions. Have all shareholders in attendance submitted their yellow cards? Okay, if there are no questions, I will now close the poll. The staff of Automic will now process the poll, and the results will be declared on each resolution. These results will be released on the announcements platform of the ASX and published on the company's website once they are available. I'll now hand over to Managing Director and CEO, Dr. Daniel Tillett, to give his presentation, after which there will be opportunities for questions. Thank you.
Welcome, everyone. It's been a very interesting 12 months since I was standing up here last time with a bit of surprise. I think last year a lot happened.
This year has been where we've really sort of done the various things that needed to get done, put the foundations in place, tick off all the activities, and set ourselves up for the upcoming clinical trial. It's been a very interesting time. It's been great working with my two fellow directors, Pete and Serge, and it really is a new, new, new race and something I've actually really enjoyed working with. So the team as well, I'd like to thank them. They've really, after what was quite a difficult 2023, really come together, really dug in, and done an amazing job getting RC220 ready for the clinic. And that was no small job. Bringing any drug to market is a major undertaking. Bringing RC220, which had a lot of problems, the ability to be able to give the bisantrene to patients was something that Lederle struggled with.
They were vastly a company that asked, and they weren't able to achieve that. Then some of you will have seen the videos from some of the old hands at Lederle where they spoke about some of the difficulties they faced. To be able to solve those problems really is a credit to the team. I'm not going to spend any time on the important notice and disclaimer. I just want to give you a bit of an overview of the share price. We've had a good recovery from where we were last year. We were below AUD 0.70 for a while. We've managed to pick back up. We're sitting around that sort of AUD 1.50 space, which is not ideal. I think it should be a lot higher, but I think of the positives of that. There's a great opportunity to acquire more shares at a low price.
So for those of you who have been buying, thank you. For those of you who supported the capital raise that we did, the options, thank you as well. And that was really well taken up by most of the shareholders. We have the piggyback options to come. 2026 really does set us up really well. We're in a great situation. Many of you are investors in other biotechs out there and have really seen what happens if you get yourself into a real bind, if you run out of capital or your spending gets out of control. We've been very much focused on ensuring that we can actually accomplish what we need to accomplish within the capacity and the resources we have and make sure that the money that we have is spent wisely and generates value for our shareholders. Obviously, you have been introduced to the board.
I won't go through that again. Same with the management team and also the team here, so most of the people are here, so recognize these faces. They'll talk to you. Please do not harass them for price-sensitive information. I know this is what you want to do. You want to go up to Michelle and you want to ask her, "When is the clinical trial starting?" We will tell you everything we can as soon as we can. We have an ethos at Race of keeping our shareholders as informed as we possibly can, but certain pieces of information, price-sensitive, can only be released by the ASX, and they can only be done when we actually have a date, so as much as you want to know, we can't actually tell you.
So 2024, as I mentioned sort of at the beginning, it's been a real year of significant progress. A lot has happened. The development of RC220 and bringing that through GMP to have something that can actually put into a patient has been quite a major success. This was not a simple thing to do. There are not many facilities around the world that can actually handle a drug like bisantrene in the form of RC220. There is a lot of complexity around the safety studies. If you remember back, this was originally developed back in the 1970s and 1980s before GLP existed. So all that safety study had to be repeated. It's almost from the perspective of the regulatory process as though RC220 or bisantrene was a completely new drug. And so we had to go through that process.
It's an area that is very complex, very legalistic, generates an enormous amount of paperwork, as the team knows. I think they spend half their time reviewing reports from various organizations and correcting errors. But the process is super important. All of the work that's been done has been done to the highest possible standards or over the standards. We don't need to have GMP material to run a phase I in Australia. We do need GMP material and these GLP studies if we want to have an IND or go overseas. We've done this to a really high standard so that if we have a partnership discussion and that partner comes in and wants to look at our CMC package, they're comfortable that we've done things correctly.
And the number of drugs that have failed because CMC was not done correctly is quite notorious, and I'm sure Serge has got plenty of horror stories over the years he can tell you about during the discussion. Also, we released some sort of preclinical data along the way. The bisantrene continues to be a very interesting drug, far more interesting than it really has any rights to be. For such a simple chemical, structurally wise, it turns out to have an amazing amount of important properties and discovery that have been made by the team that really add a lot of value to the shareholders. You've got lucky. I think Lederle recognized they had something pretty amazing and persevered with the bisantrene long after they should have thrown it away. And they had an understanding it was something kind of unique.
And the more we've learned about the bisantrene, the more we've realized that actually this is something that is actually pretty amazing. And as we start to go and explore all those properties, they generate IP and knowledge that then drives forward. And I think a lot of this comes to, as we've been doing a lot of work in discovering the mechanism of action, particularly around the cardio protection. For those of you who have been investors for a long time, initially that started out just as an idea.
Then we did some cell-based work, then some animal studies, then try and pull apart the molecular biology of that down to the sort of protein level, the DNA level, and try and understand how is a drug like the Santorini able to protect the heart from anthracyclines or chemotherapy, but also not protect the cancer or actually add to the cancer. So that's been quite a journey scientifically. It's been a very difficult problem. The team's done an amazing job of figuring that out. Unfortunately, I can't yet share that with you, how this actually works. But some of these discoveries along the way have really opened up more than just cardio protection. And I'll talk about that now. So something that we've spoken about, I've spoken about to many of you, about the effects of chemotherapy on patients as they go through this process.
It's not an easy thing for those of you who have been through chemotherapy, and I know there's some of you here. It really is a very nasty process, and it leaves you permanently damaged, not only your heart, but your entire body. The rough rule of thumb is you're about 10 to 15 years older at the end of the chemotherapy process than you were before. It varies from person to person. Some people come through it pretty well. They don't really suffer too much from that process. And other people are aged extremely 25 years type thing. It really is a very harsh process. The reason why you go through this process is because it works. Unfortunately, cancer is a terrible disease. It's incredibly difficult to treat. And one of the most powerful tools we've had for the last almost 70 years now has been chemotherapy.
But this problem that exists, this accelerated aging that comes from chemotherapy, is a huge problem, far bigger than just the damage to the heart or any particular organ. It's the whole systems together. Everything gets damaged by chemotherapy. So your kidneys get damaged, your liver gets damaged, your cardiovascular system, your lungs, your brain, everything gets damaged in this process, your muscles. All of those add up together. If you think about it, for those of you, like I said, there's lots of young people here in the audience. You've lived through what happens just with normal aging. You can imagine how you felt 15 years ago, how much younger you were. To have that in three months to age 15 years physically is an amazingly bad thing to have happen to you.
So what have we discovered as we've been going through the mechanism of action around how the bisantrene works to protect the heart? We've discovered that we haven't discovered this. This has been actually well known for a long time, is that all anthracyclines cause and all chemotherapies cause this accelerated aging problem. All tissues get damaged by this. They're not targeted in any particular way. You get 10-15 years. The important thing that we have really sort of come to focus on as we've learned more and more is that anthracycline cardiotoxicity is really just one aspect of the problem of chemotherapeutic aging that occurs is accelerated aging. The reason why people focus on the heart is the heart has no regenerative capacity at all and has little in the way of spare capacity in general.
So unless you're very young, you really have no spare capacity in your heart, and any damage to that will make an impact on your cardiovascular fitness and the ability to actually do things. Once you get down to a certain level, you become functionally disabled. You're no longer able to do the sort of normal things that you were able to do previously. For example, walk up a set of stairs becomes impossible. Getting out of your chair may become impossible. Walking to the shops, doing gardening, all those sorts of things, any sort of activity that you might have once done then becomes impossible. So all of this comes together in the mechanism of action work.
So as we've learned how the bisantrene prevents the damage to the cardiovascular system, we realize that exact same mechanism of action applies to all cells in the body that are not replicating, which is pretty much all the cells that get damaged by chemotherapy. And so if we're protecting the heart, the cardiovascular system from this damage, we're also protecting the other tissues in the body. So that actually kind of makes the story much more interesting, I think, in many ways and much more important. It's not only just about the heart. It's also about kidney function. For example, chemotherapy, anthracyclines damage your kidney. When you get down to a certain level of spare capacity in your kidney, you have kidney failure or you're on dialysis and you don't have a very long life expectancy ahead of you. It's a really dangerous thing to have.
So to be able to prevent that from occurring through is something that really is quite important. The thing, the other aspect of this is utilizing chemotherapeutic drugs to their full potential. Doctors have become more concerned about the side effects of chemotherapy as they've gone on. They recognize this accelerated aging and recognize all the damage it does. And so they become reluctant to use it. And that comes at the expense of treating the cancer correctly. So if you cut down the dose or cut down the number of cycles, you put that patient more likely to get a relapse or have the cancer come back, be less likely to get to a cure. And that's not a great outcome. It's a kind of a balancing act. But by changing, they're able to protect it from the damage that's occurring.
You also are able to prevent the cancer from coming back as well by being able to treat more aggressively. That's a really important aspect of that. I mentioned a bit about anthracyclines. It's really important to understand that anthracyclines as a class continue to be very widely used. They're extremely effective. If anything, they're underutilized. This, as I mentioned, this problem of the damage they cause has made many doctors reluctant to use them, where they really would, all things being equal, would use them because they're so effective. They're very generalized. They work across a wide range of different cancers, and particularly where you don't have a target to go after. You don't have a particular mutation where there's a targeted drug for, they will work. There's been a lot of excitement in the last 10 years around immunotherapy.
But immunotherapy is only a small percentage of cancers respond to that, as it comes with many side effects, very serious. It's not uncommon for a patient to get an immunotherapy. The immune system suddenly decides to say, "Take their heart," and they die within a week. These sorts of things happen all the time. So I think cancer treatments come with a lot of side effects. One of the reasons that anthracyclines still remain important is their use continues to grow. The reason why this continues to grow is a combination of different factors. Basically, there's more people, the populations continue to grow, and the age of the populations continuing to grow as well.
So even though relatively, there's a percentage drop off in the number of patients that get treated with an anthracycline has fallen, the number of cancer patients is growing faster than the falloff in anthracycline use. The scale of the use is just absolutely massive. Used all around the world, a real focus in China, a combination of historical plus just the sheer size of that market, but everywhere around the world. I think this slide has come from the Triangle Report from April of 2023. I don't believe the Indian number is very unbelievable, but getting accurate numbers on the use of anthracyclines in India is very difficult to come by. I spoke a bit about RC220 at the beginning, about what we've done with that and why it's so important. The bisantrene has got a great clinical history behind it.
Lederle ran a lot of trials, around 50 trials across a wide range of different cancers. Some of it worked well, some of it didn't, all sorts of different reasons. But where they really focused their attention on was breast cancer and acute myeloid leukemia. In acute myeloid leukemia, we've run what's helped support two trials in modern times in Israel, two phase IIs, where we got 40% response rate in really difficult to treat patients. The most amazing thing about that 40% is it matches up to the historical. There are very few drugs where they were developed 40 years ago that still have the same sort of response rate. The reason why is the patients these days are far more heavily treated before they get to a new treatment.
Acute myeloid leukemia, when the bisantrene was first tested, was tested on basically they failed the initial chemotherapy, seven plus three or five plus three, and then they'd go straight to an experimental treatment like the bisantrene. In Israel, these patients had failed either in the first trial, three previous lines of treatment, so this was the fourth line of treatment, or in the second trial, it was four previous lines. That's the median. Some of them were up to nine different lines of treatment. And yet still, we have this 40% response rate. Very interesting. In the breast cancer trial, which was unfortunately a failure for a bunch of reasons, and we could probably spend hours talking about what went on in that trial, but it actually generated a huge amount of data that's really valuable to us.
The patients in that trial were given many, many cycles, a median of 17 cycles of bisantrene without cardiovascular problems, really speaking to the safety of bisantrene. The patients, even though they didn't respond, their tumors didn't respond. The cancer was only like 12%, I think, from memory compared to 28% for doxorubicin. They lived just as long, and that's pretty amazing, so even though only a relatively small number of cancers responded, they kept the patient alive and they were able to keep the cancer under control, and this is actually one of the areas where just shrinking a tumor is not necessarily the thing that's most important. It's actually keeping the patient alive and healthy with a functioning heart and all the rest of it is what really matters.
The other thing too is it gives a really good idea of the sort of side effect profile on a large number of patients. To run a trial like this today would cost hundreds of millions of dollars. So we get a lot of data out of that historical thing. With RC220, what we went about, the team went about was, can we come up with a formulation that would solve the reason for why Lederle dropped the bisantrene, which was this crystallization in the blood problem, but maintain the same properties as the original? And so basically, 30 seconds after it's in the bloodstream, the bisantrene is exactly the same as the old form versus the new form.
Basically, I only have to keep the bisantrene in solution for 30 seconds, and by that stage, it's been spread out enough that it's not high enough concentration to crystallize out in the blood, and so that's what we've done. That gives us a lot of confidence that we can rely on the historical data to know how RC220 is going to work. So while technically RC220 is a first-in-man drug, because the drug is the actual formulation, not the actual chemical, we have pretty good confidence of exactly what sort of properties, toxicities, side effects, and effectiveness, and that's what we've seen certainly in the preclinical data. So the way it's worked in animals, it's worked exactly like the old form. It's also created new IP, which is super important. That's what you sell to a large pharma company is IP, not ideas. They don't want to buy ideas.
They want to buy something they can actually protect and make money from. And we have basically now something that I think is commercially attractive. The job now for us is to prove out cardio protection or the anti-aging, accelerated aging aspect and show that this actually works in humans exactly the same way as it works in animals. What's the sort of scale? The scale is so ridiculously large that if I start to talk to people about this, they go, "This can't possibly be real." You look here, this is the annual revenue of bisantrene . This is based on quite a low price for a new drug in the oncology space, $15,000 a cycle.
We already went to the payers as part of the Triangle Report analysis and said, "What would they be willing to pay?" They wouldn't start to push back on pricing until it got above $20,000 a cycle. So $15,000 is very reasonable. They didn't have any problem with that sort of price. We looked at sort of what sort of penetration, what percentage of the market would you have to capture to get a $7 billion a year market? It's 3%. And the reason why is we're not replacing anything. We're adding on top of what's already existing. And that's a really unique opportunity in the cancer space. We're not having to push out a drug that already exists. We're not having to fight against the drug reps and the pharmaceutical companies that occupy that space right now and try and convince doctors to use this thing that's better.
This is something that can be used on top of what they're already currently doing, and you're looking there at a massive market. Just doxorubicin alone, $1.5 billion a year. What does that mean for something like if you added the bisantrene on top of that? It means that basically there's no bottom end on the market. If all we could achieve was $1.5 billion a year in sales US, at 5 times or 10 times sales, which is quite sort of reasonable, I think the average is like 23 times sales in the industry, you're talking a very large number. That's as a generic, let alone as something that's got IP over it as a new product, so the opportunity is massive. The key, though, is making sure we collect the data that allows us to capture that value.
We come to the clinical strategy. So this is our clinical pipelines. We've spoken about this many times before. RC110, that was the original formulation, the LIP, basically a version of what Lederle originally developed. Very effective all the way through phase II, all the way through could go straight to phase III if you wanted to. But commercially, it doesn't make sense to continue to advance RC110. We'd only compete with RC220. No one would use RC110 if RC220 was on the market. All you would be doing is attacking your own market with a generic drug, not a very wise approach. So we've now focused entirely onto RC220. We're no longer doing any further development with RC110. And we're focused on two areas, basically cardio protection, and the second one is anti-cancer directly. So you can use the bisantrene in two ways.
You can use it basically in combination with an anthracycline to try and protect the body from the damage that anthracyclines cause, plus add to the anti-cancer, plus also look at the effect on M6A, which is now another whole topic in itself. The other way to use the bisantrene is as an anti-cancer agent directly on its own or in combination with non-anthracycline drugs. The lead indication for that is acute myeloid leukemia. There's no particular reason why acute myeloid leukemia may be the best opportunity in that space, but it's certainly an opportunity that we have a lot of data for. So that still remains attractive. So we're about to start very shortly. We'll have the ethics application in, and we'll have patients being treated in the cardioprotection trial as soon as we possibly can.
We're waiting for a formal request from an Australian investigator on the acute myeloid leukemia so we can make an assessment whether that's something we want to support or not. There's a fair bit of expense in supporting even an investigator-initiated trial. There's a lot of oversight to that, and you want to make sure that you get value for money for the shareholders. Of course, just last week, we announced around the M6A molecule development. We've had a program going for the last couple of years in collaboration with Monash University, looking around developing new molecules that can target FTO directly. That's a very exciting opportunity. We've got a really interesting way about solving that problem, trying to overcome some of the difficulties that other people in the space have had developing drugs in that space. That's generated some really interesting data.
We need to make a decision as a company what we're going to do next. We haven't yet. The results have only sort of come in very recently. We haven't had a real sit-down, a serious discussion about what to do next with that. If people want to ask me questions about what are we going to do, I can't give you an answer other than it's a great start and that we can actually generate potentially a lot of value, but it's not something that's done lightly. It's a major undertaking. It costs a lot of money and will take some time. We're a small company with limited resources, and we have to make really wise decisions and try and avoid some of the difficulties that you can get into if you spend far more than you actually have or can raise.
To go a little bit of detail about the RC220 phase Ia/Ib trial, very much similar to what was proposed last year, a little bit more focused outside just the cardiovascular side of things and looking more across the entire body. We'll be measuring things like kidney function, liver function, skeletal muscle. All of these things can be measured in a trial. And you can start to see the impact. Are we able to prevent some of the damage that anthracyclines can cause? This will take a bit of time, particularly the 1a. Unfortunately, the patients that are in a 1a trial, first-in-man, have been through the usual. They've been through the works, have been severely damaged from a lot of treatment earlier. You don't go straight into a first-in-human trial if you've just been diagnosed with cancer. You generally have failed many different things.
So those initial patients will all be about safety and working out the tolerable dose that can be used. The 1b stage will start to give us clean data and tell us whether this is actually going to work. So this will be a little bit off, but this is where I think the real value of the company comes. We're able to do this relatively cheaply and hopefully in a relatively short period of time. It'll depend a little bit on how many sites we can get up, but so far everything's progressing well, not as fast as I would like. But everything that can be done is being done to ensure this is done as quickly as possible.
But the most important thing is to ensure that the data that's collected is valuable and interpretable, which sometimes is not the case if you run a trial and rush into it. Just mentioned there, nice picture there of Mike. It was a quote from him. Mike's been leading the team that's been involved in this area. It's an area that I'm not an expert in. I'm not a medicinal chemist by background, but it's been very interesting watching this program develop and progress and generate a lot of very exciting leads that can be followed up and turned into from a lead into something that's going to become a candidate that could be then potentially taken through the preclinical testing and manufacturing and then go on ultimately to be treated in a patient. The whole area of M6A is completely wide open at the moment.
No one really knows where is the best place to use it, which are the best diseases. No one's got a good drug that can target FTO. And until that comes along, we don't really know. So there's a huge lot of potential. There's enormous excitement within the scientific community. There's a new paper on M6A or FTO basically every day coming out saying it's important in this disease or that disease, cancer, metabolic disease, diabetes, everything. But no one yet knows where to best use it. So it's exciting, but unfortunately, it's a lot of science, I guess, on that side. And over time, we'll get to and the scientific community will learn where is the best place to use these types of drugs. Hopefully, Race will be part of that. So I'll just finish up on sort of the key highlights about Race and the strategy.
I think that the thing that for me personally, I like about the bisantrene, apart from the fact I find it very interesting that such a boring old molecule could be so interesting scientifically, it's been de-risked and clinically proven. All the development work we've done is we've built upon the historical data. We've made sure that we keep the properties from the past we wanted to keep, and this gives us a really good idea of success. Normally, when you develop a totally new drug, you've got about 3% chance of that making it all the way through the market. When you're developing a drug like the bisantrene on the same thing it was developed for, anti-cancer, probability of success is vastly higher. As an investor, that's very attractive to me. I don't like to gamble on 3%.
I like to bet on an 80%, 90%, 95% probability of success. It solves something that's real and a really significant health problem. That's this accelerated aging. Taking 15 years off the life of everyone that gets treated with chemotherapy is not a good thing and has an enormous impact across the board. Basically, people die 15 years, all things being equal, than they should have otherwise, and that's even if they're cured of their cancer. Just all the aging that goes on is really terrible, so the last thing we need to be doing is making older people, old people older or sick people sicker, and if we can do something about this, I think that's really amazing. We're building a drug that'll be used on top of what's already out there. We're not having to displace anything.
From a commercial perspective, it's very attractive to be able to say, "Okay, the market already exists. The drugs are already getting used. The doctors are very familiar with them." You're just taking away the thing that stops them from using them optimally. Obviously, low-cost development is very important. We're an Australian biotech company. We don't have AUD 300 million in the bank to spend doing dozens and dozens of trials. We have to be smart and intelligent, use the funds that we have, use all the strengths we have by being an Australian company, use that wisely, spend our shareholders' resources wisely, and bring something through that has the potential of getting accelerated approval. And I think we do have that. And the final thing I think is management has proven technical deal and ASX track record. In fact, I'm the least impressive person on the board.
Serge and Pete have decades of experience in the space. To have a board of the quality that Race is lucky to have really is amazing. Everyone within Race is a scientist. It's just the quality, the value that everyone puts in, and what you get for every dollar spent is really amazing. And there's a real belief that spending wisely, generating good quality data is important and generating a return for our shareholders is paramount.
And at that point, I'll pause and turn it up to questions.
So yeah, just with the anti-aging effects noticed with bisantrene, what have you actually seen to declare that, I suppose, and also going forward, are there specific tissues in the body that you'll be concentrating to test?
Yes. So the answer to that is a lot of this is tied up in the mechanism of action work.
I can't really talk to you a lot about the preclinical stuff, but the tissues that I'm most concerned about are the tissues that don't have any ability to repair themselves. For example, your kidneys are a good example. When you damage your kidneys, they can recover a little bit depending on where in the kidney. But typically, once your kidneys get damaged, they don't get better on their own. You want to make sure you don't damage your kidneys. With kidney damage, you can have a lot of damage until you get down to about 12% of what you were born with. When you get to that level, then you get kidney failure. At that point, you have to go on dialysis and all the rest of it.
So there's a lot of some tissues got more spare capacity than others, but all of them get accelerated towards that. And if you lived long enough, you would eventually, your kidneys would wear out. But it happens to all the tissues in your body that don't have regenerative capacity a lot.
And what's the method of actually testing those kidney cells? How is that?
Yeah. So if you start to suffer kidney failure, you start to, you can see that in, for example, your kidneys are not as good at filtering out. So you get spillover of various things into your urine. So you just have to measure the urine for a particular marker. It's very well established what is the cause of kidney damage and whether you can detect it.
So you can do things like biopsies as well, but you don't really want to take a kidney biopsy of a cancer patient unless you mentioned brain. You can measure it by, yeah, you can measure it directly from urine. Some of the other things you can measure using things like MRI or CT scans, for example, skeletal muscle is a good one. So as you get older, you lose your skeletal muscle. And as you get to a certain stage, you become what's called frail. And you become likely to fall over, break your hip, those sorts of things. Your bone, for example, even though your bone will go through an age. So all of the tissues in your body go through an aging process. So anything that accelerates that, you can measure that process.
Right. And this will be sort of incorporated into phase Ia and I b.
Yes. Of course, all those things you can measure in the trial, so we're not just focusing entirely on the heart or the cardiovascular system. We can actually look right across the whole body of the patient, and so, okay, we're protecting the kidneys, we're protecting the skeletal muscle, we're protecting the liver. All these things can actually all go together, so it's really nice. We're building upon. There's nothing from us, there's nothing particularly new. This has been studied by millions of scientists and doctors who have worked out all this sort of stuff. We're just saying, okay, we're going to look at this now going forward.
Thanks.
Hi, Daniel. It was originally announced in the new molecule program, announced in the share purchase plan, that about AUD 800,000 would be allocated to the program.
And then in 2022, when it was announced, it was going to use about 200 or close to 270,000. In the update, in the recent update, it was noted there were resource shortages in the program. I was just wondering how much capital actually ended up being utilized for the program.
Well, that program was not just this one aspect. So we've done an awful lot of other work internally, which we can't discuss around development and stuff. So you can work backwards from that if you want. If you say, okay, we're this much and we've spent this much allocated and there's a gap, must have been spent on something else. So not everything we've announced to date. There's a lot of activity going on. I know this is controversial, the iceberg analogy. Not allowed to mention icebergs anymore, but that's really true.
A lot of the activity that goes on at Race is not stuff we talk about, and that's for IP reasons. We just can't talk about new molecules. We can't talk about it until they're protected. And that's tied to you want to get maximum life out of the IP. For example, RC220, we only just put in the patent about a month ago, I think, or a bit over a month ago, even though we've had that formulation for a couple of years now. And the reason for that is to maximize the IP lifespan. And that gives value, add two years extra to the IP, and that adds a lot of value to the drug going forward. A lot of activity going on within Race that's not been spoken about, which you will hear eventually as time goes by.
Thank you.
Just a quick follow-up. There's obviously your decisions about what the next steps are with the program. Is it possible that the program for further development can be outsourced overseas to make use of the 20 million R&D rebate?
Yes. You could do a whole bunch of different options, anywhere from selling the whole project off to partnering to doing some of the work internally, adding new resources. There's just so many options that could be done. This is something we'll discuss over the weeks and months ahead. What is the best option for that? We are resource-constrained as a company, and we don't spend, we don't have lots of money sitting around just waiting to be spent on things like this. We don't enter lightly into new projects unless we're convinced this is the right thing to do.
So working on what the best options are is something we're going to have a lot of discussion about going forward. So there are just so many things. It just opens up a whole lot of opportunities. Working out what is the best opportunity for Race at this particular point in time is difficult. Might even be, oh, well, maybe we just park it for the moment. We don't do anything with it because we don't have the resources, but we might, down the track, we might have more resources. We just don't know. So it just depends on lots and lots of factors.
Thank you.
Hi, Daniel. Just a follow-up on the anti-aging, given that's the new topic today. So we'll have to have something new to give you guys. Otherwise, absolutely. So I see that you have sort of updated the clinical trial slide.
Does that require new paperwork for submission? Does it require or introduce any new risks towards the outcomes?
Not really. It's more just what we record. So we record more information on things that you wouldn't otherwise. In theory, it increases the cost slightly, but they're pretty minor to add in the various tests that need to get done or relatively minor things in the greater scheme of things. So it's not really significant, any of those things. So it's basically, if we think that there's a good reason for it, and so we have to be able to justify that, we can't just add in something into a clinical trial without any supporting evidence for that, because otherwise, patient-wise, the patient consenting to have something done. But that does allow us to collect more data and really discover.
It might turn out that bisantrene doesn't work at all as a cardiac protective drug. It doesn't do anything to the heart, but it protects the muscle tissue, skeletal muscle. If it did that, it'd still be a fantastic drug, and people would still use it purely for that, or it might just protect the kidneys. That would be a fantastic outcome. So the more opportunities we can look at, the more opportunities we've got to pick up. The more benefit we can provide from a pharmacoeconomic point of view, the more we can charge for that drug. Because you can go and argue with a payer, look at how much you're saving because it's going to prevent this from occurring, this from occurring, and this from occurring. Therefore, you can charge a higher amount. So it can only be helpful.
It gives us more opportunities to have a successful outcome and also to be able to charge more for the drug at the end of the process or whoever owns bisantrene at the end of the process.
Okay. Thank you. Just to follow up on that. So the discovery for this anti-aging, did that come out of the method of action for cardio protection?
Yeah. So once we learned how bisantrene works to protect the heart, muscle, cardiovascular system from the damage, that goes, oh, that's exactly the same problem occurs in all these other tissues. So it's just an immediate fallout from the mechanism of action. Once you know how something works, you can then go and look where that will be exactly the same thing. Before that, you've just got an empirical discovery. You can't tell where it might apply. So mechanisms of action work.
You might think, oh, well, why did we bother doing this? It's not just a nice to have. It's actually generated an enormous amount of value. It's been a really difficult problem. It's not been easy because bisantrene is a very broad active agent. The anthracyclines are very broad. They affect many, many, many proteins and systems within the body. So working on exactly which ones are important is not a straightforward set of work. So I think the guys that have been doing this will tell you that it's not easy, but they've got there, which I think is the most important thing. But I have a couple of things there. So the anti-aging thing came about because we were constantly referring to the fact that the effect on VO2 peak that we're seeing in these clinical studies was akin to 10 to 15 years of aging.
Then when we were looking at the mechanism of action, we then said, well, what's happening in all the other tissues? And so it was very much a reading the literature, a bit of research, and realized, right, there is evidence everywhere you look for damage in this aging process. I'll just give you a couple of bits of some of the ideas we've got for what to look for. So some of you will have heard of the term epigenetics, which is changes on the DNA that affect how a gene is regulated. And what they've found is that that DNA methylome, as it's called, changes in a very predictable way as you age.
If you actually, obviously not a cancer patient, but if you looked at the DNA methylome of myself, Serge, yourself, they would be able to look at that DNA and tell you to within probably about two years, either side, how old you are. Some of the papers, like the one, the commentary on one of those papers, they show this acceleration in epigenetic aging. That's something that's very, very easy to measure. The other area is senescence, which is that cells basically, they don't die, but they kind of switch off and don't do what they were programmed to do. Then they produce a lot of inflammatory factors. As we age, we get a lot of an increase in inflammation. Again, something that's very, very easy to measure. We can measure those senescence markers in the bloodstream.
These are just some of the ideas. And of course, we've got, we will be doing some animal work. We will be looking at primary human cells in vitro, but we're just about to get human samples. And that's where I think it'll get very, very exciting. And that's the sort of thing that a company that markets cancer drugs is going to be very, very interested in. If the patients knew upfront that this was going to age them by, say, a decade, I think it would shock a lot of people. And of course, the doctors don't mention it because there's nothing they can do about it. Whereas if we're right, and we've got a lot of work to do to prove this out, but if we're right, then this will become the key marketing message for bisantrene RC220. So sorry to add that in.
Yeah, no, no, no. I think it's very important. There's been a lot of discovery about what actually happens in aging, so we haven't spoken much about it. I don't know how many people here study the science of aging. There's been a lot of discoveries about how to measure it very accurately. This methylome, there's what's called a methylome clock. You can actually take that and see how much, and this is something you can just measure from blood, so it's really, these sorts of things are really great to have in a study, and people have done this with chemotherapy drugs. I can actually see this 10 years directly. It's not just anecdotal. It doesn't just show up in the fact that all the diseases of aging are accelerated.
But actually, you can measure it directly in the DNA of a patient that's been treated with a chemotherapeutic drug. So being able to have something to do about that actually really makes, I guess, increases the excitement about and the generalizability about bisantrene. And it's really quite an amazing opportunity there. So I've been interested in anti-aging for ages. Pete has been as well. And we both started talking about this, and we just got so excited. Yeah, yeah. Yes. I can't say there's anything good about aging whatsoever. But doing something about it is something that's pretty amazing. And having the ability to also treat the cancer better, which we've got to remember, the reason why these patients are being exposed to these incredibly toxic drugs is because they've got a terrible disease that we need to treat better.
And to be able to do two things at the same time is really an amazing opportunity.
I've just got a question about the global spread of anthracycline use that you had to figure out on the display before, and we've seen it a number of times. The United States is about 730-740-odd thousand doses per year. You mentioned that you're not quite convinced about the data from India. How convinced are you on the data from China? It's more than just a pro-rata of the population.
Yeah, I know.
From the United States, it's about more than double that even.
Yeah. So there's different places in the world have clinicians develop, I guess you call it habits, and they develop protocols they're comfortable with. So Australia and the U.S., you would think would be quite similar. There's actually a lot of differences.
You'll have the same patient, if they're being treated in Australia, would be treated with a completely different set of drugs than a patient in the United States. That applies across the board. China, historically, anthracycline because they're very cheap and extremely effective, tended to be used in countries that don't have as much resources. In fact, huge amounts of anthracycline are used in places like Africa or the Middle East and all of those where it's hard to get actual hard numbers on because there's nobody there recording these sorts of things. There's a lot of anthracycline. You can look at the top end. You can look at the total number. Where those anthracyclines end up is hard to sometimes challenge. If you ask oncologists around the world, what's their number one drug in their arsenal? What's the most essential drug?
So WHO asked this of oncologists a couple of years ago, and doxorubicin was their number one drug. And the reason why is it just works for so many different cancers, and it's effective. And it's cheap. So that is, but as countries get wealthier, there's a transition towards more expensive treatments, cell therapies and all the like. If you're, I don't know, like if you're in the Congo, you're not going to get treated with some CAR-T or something like this. It's just not going to happen. But it's quite possible that if you're middle class, that you would get an anthracycline treatment that would be effective under those conditions. So, yeah, ultimately, it doesn't really matter. If it turned out that it was only 20 million or 10 million, they're all huge numbers anyway.
So ultimately, it's got to do with really what the most important thing is that the market's still growing, as people are still producing anthracyclines in a very, very large and existing market with a huge problem. But if I can just add, obviously, we're very, very interested in that China number. And there's been some very, very innovative partnering deals done between Western companies and Chinese companies. And there are a lot of companies that are just bringing in Western drugs. So as part of our commercialization activity, in fact, we were talking about this very recently, we want to go and get some of our own data on exactly who's using it, how much are they using, what regimens they're using it in, does it vary region to region, or whether you're in a big city center or out in the sticks in China.
So at some point, we'll commission that sort of study. As you imagine, those sorts of studies don't come cheap because it's a shoe leather type job, going and talking to a lot of different people. So we would commission that when we need that data. And obviously, if we're talking about partnering a drug, we need to know how much of it we think could possibly be used. So we will need accurate data on that. But certainly, I mean, we've all looked at that graph and went, well, there seems to be a lot of inconsistencies there. And that's probably just reflecting the different data sources that have been used to put that together. But if we're really, really serious about it, we will need to go and commission our own market research. Yeah. A lot of places, it's just quality of data on usage.
It's really hard to get. In fact, Australia is actually one of the best places in the world. We actually get a, you can get a subset right through the Medicare data, like 10%. You can get really accurate. In Australia, anthracycline use is continuing to grow. It's still quite large. So there is a lot of data out there, but some of it is not great. So, yeah, that's, but it's kind of semi-irrelevant for what the problem we have now. Ultimately, we'll have a big market. If it's double the size of what we thought or half the size, it's not going to really make a huge difference to the valuation of Race.
Sorry, just one further question. This goes to, I think, slide number 39 on your presentation. It was about the NMR.
It might be something that I'm probably more hoping that, yeah, that one there, that Dr. Kelso may be able to speak to if I don't put him on the spot too much. I'm curious about those charts that you've got there and maybe just a little bit of discussion around those, just so I can understand that a little bit.
They're just saying that we've made these, yeah, they're just showing the protein. That's how you study this process. It gives you an idea of how this is done by our NMR. These are the top ones, mass spec. We haven't really gone into a lot of detail because it's very exceptionally nerdy technical chemistry stuff. Was there any specific question?
There's an obvious spike on the top right there, but also a smaller spike.
Yeah, let me just explain what that figure is.
All of the red lines you can see are molecular masses. So a protein will have, when you take a mass spectrum like that, a number of different peaks because it can ionize to different charge states, they're called. So all of those lines look like a big mess of many different species. But what you do is you do a computational deconvolution and generates the figure on the right, which is a single line that tells you that's the molecular weight of the protein FTO that's being measured here. So it wasn't explained in the release, but I guess scientists understand that. Molecular scientists anyway. Yeah.
That bottom one.
Yeah. It turns out Serge is an expert in NMR. So he's PhD and postdoc.
So that bottom one's a really interesting one because it tells you basically that elements of the protein are flipping around. It's not conformation.
There's no real conformation. The beautiful thing would be once we start to screen for potentially inhibitors, you're going to start to potentially see this blob move out, so there'll be changes. If there's binding of a molecule, that will change, and that will tell you immediately that you found something that's binding, which is really exciting, so that tells you there's some structure. These little pieces that are out on either side tell you that parts of the protein are structured, but this big, massive glob in the middle is telling you that there's a part of the molecule that's unstructured, and hopefully, when you start to screen for your small molecules and you get changes in there, that's telling you there's some structural changes happening, so that's what it's valuable.
A lot of this is tied to why FTO is a difficult drug, a difficult protein to make drugs for and where to actually try and make a drug to this. So we don't want to really get into a lot of discussion about this because the IP is valuable. But there is value in this. We just kind of liked these pictures. I like them anyway. Gives you something to look at rather than just words. Who wants to see pages and pages of just words? But it is part of the process that went through this. It was actually quite complicated to get to this point. It actually took quite a long time, about probably 12 months or so, I think, to get this. Because it's not straightforward to do that.
Robert Canelli, again, at first glance, my question might seem a little bit flippant.
But before we leave today, could you spray us with RC220 bisantrene?
With pleasure. Which of you brought some? Hello?
My name's Fake Tan.
That's what happens. So talking to Von Hoff about this, so it turns out that actually turns people orange. And the other one is mitoxantrone, which is the other drug that Lederle developed, turns people silver. And then looking like the Tin Man as a consequence. So, yeah, these drugs actually have quite a color to them, and they do end up under the skin. They end up everywhere in the body. Your urine also comes out really nice color as well. So these. I'm not encouraging anyone. These are not things you take lightly. Interestingly, Von Hoff published a paper back in 1981 or something like this saying, do all cancer drugs have a color that work?
And can you use this as a means of actually saying, this chemical will actually work as an anti-cancer drug. And if it doesn't have a color, it's not going to work. And if it does have a color, it'll work. I think he was being just silly. I even think he thought he was being silly with this. But this is actually quite an important area. A lot of the cancer drugs actually have quite a color. So doxorubicin is kind of a red. One of its nicknames is the Red Devil. And this sort of thing happens a lot. So, yeah, you don't want to be sprayed with bisantrene. Although it is a very good antiseptic, it's very good at killing bacteria. I've got, sorry, I want to go back to the new anti-aging feature of bisantrene.
But before I do, I just wanted to say from a shareholder thank you to the Race team up the back here that we're all going to pester later on. So thanks, guys. So I would have thought this is actually fairly big news for the company that bisantrenes are anti-aging and or potentially anti-aging and maybe even market-sensitive just to find out at an AGM. So that's my first point. The second thing is, and I may have misunderstood this, is this something you've deduced from the mode of operation or have you done actually any preclinical work on it? And will you be releasing preclinical work on it?
Yeah. So that's the reason why this is not is because we haven't been able to release any data to support this.
We can't release any data because it ties back to the mechanism of action work, which is going into a very large high impact paper. The journal article. So what we want to do, the reason why we haven't just published the mechanism of action work is not only we want to ensure that we get the maximum value, we want to get as many people in this pharmaceutical space to look at this and go, actually, this is actually something that's really important. We should get involved in that and open doors. The way to do that is to publish in a high-impact journal. In order to publish in a high-impact journal, you can't have published anywhere else before. So you can end up ruining the ability.
So if we would tell you guys, I've got no problem with telling everyone, that would then prevent us from publishing in this high-impact journal, which would then prevent people from being able to see the results of this and get the impact from that and the value from that. So to look after the shareholders' interests, we're holding back. As much as I would love to tell you how it works, because it's very clever, I think, anyway. But we can't. But we will eventually. So when it goes into the journal, it'll come out and then you'll be able to read it. And we'll put a summary of what it means and all the rest of it. So you just have to be patient.
The question for Dr. Scrofani, hopefully I haven't made a meal of that name.
Firstly, as a shareholder, very excited and bullish to have you on board. Your experience, hopefully, will be an asset to all of us. I guess with your experience with CSL around strategy, working big pharma, what are some of the challenges that you can see with RACE in terms of executing our strategy? And have you been able to advise the team on some of those challenges that you may see?
Thanks for that question and those kind words. Look, I think the key point is staying on strategy. Because let me just unpack that. When you talk about strategy, it's not only what you do, but it's what you don't do. It's how you choose to prioritize key activities and fund and resource them appropriately.
The real challenge, certainly, that I've seen in the past with companies that I've dealt with that have come to CSL has been wanting to do things that are really cool or interesting to certain investigators, but are not going to take us to the point that it's going to make a difference to a partner or an acquirer down the track. So it's being really consciously choosing what we do and how we do them, recognizing that you are always asking the question, where does it take us? Where does it take us? Always second-guessing and understanding why we do what we're doing. So that's, to me, one of the critical things.
And that's been really the gratifying part of being part of this team and joining the folks, is having that ability to have rigorous debate and discussion and then saying, yep, okay, these are our priority areas. These other things that are really interesting are not going to really take us where we need to go. So we have to focus on these things. And then at some other future point, we might explore these other elements.
Okay. Are there any other questions? The whole team is going to be you want to. One more. Okay. There you go. Free hit.
Just, yeah, quickly on the NMR program. So you discussed that there is an option to outright sell the program, not asking for the figure. But do you have evaluation on what the program would be worth in that circumstance at the moment?
You see some programs like, I'm trying to think of what the Accent Therapeutics, I think they were. They were in this, but they sold off one of their programs for like $400 million. They decided to get out of that space. They were making METTL3 inhibitors and sold that off and went off into a totally different area. They were looking then at the readers rather than on the writers or the erasers, if you remember, the three things that are involved in the M6A system. That's the sort of program that they decided to do. They sold another program to somebody else for 100 million or something like that. But don't expect something like that for this. Those things happen. Sometimes it's the right fit for somebody they want to get into.
They might decide that somebody wakes up at Pfizer tomorrow and says, "We've got to be in the M6A space, look around." And they go, "Oh, these guys, we'll go and talk to them." And there might be that they might decide to go with it. But that's unlikely is probably the best way of putting it. But it does happen within the space. Yeah. And I think the important thing, I mean, speaking to what Serge said, is let's map it out properly. We've got some real handholds now on the molecule. Right. What would a drug look like coming from that program? How long would it take to get from fragment to molecules to late lead to drug candidate? And that's quite a lengthy process and is uncertain. And we had a meeting just before this AGM, and we said, "Right, let's go back.
Let's have a look at the literature, and let's pull out all the biological data that supports an FTO inhibitor being active in disease X, Y, or Z, and people knock out genes, they silence genes. There are a lot of ways you can actually get that data that's very specific to that protein. So I think we need to map this out, and then you've got to think about the clinical development path as well, so it sounds ridiculous that you can map out 12 years of a drug development or 10 years of a drug development pipeline, but it does make you then ask the question of, right, what's the patient population? Are they tractable? What else is in development that could actually impede with that, and you take that longitudinal view rather than looking at, right, what's next, because what's next inevitably leads to something else.
You can end up spending a lot of time and a lot of money going down a rabbit hole that isn't of any great value. So we want to go through that formal process of putting that. Initially, it's just a sketch, an outline of a project plan, but to understand where we need to get to and whether there are genuine value-creating steps along the way. It might be we can get to what's called a tool compound that can then get you data in animals, which it's not a drug, but enables you to say, we're having this effect by inhibiting FTO or whatever path we're looking at. So it's quite a complex process. But the devil is lying in wait for you if you think you just go, oh, let's just do another experiment. Let's just do this.
Then you end up spending a lot of time going nowhere. That's the process that we'll be going through. Just that the one thing we don't like at RACE is opportunities and big opportunities. The really most difficult thing we have is choosing what are the best out of all the possible opportunities that we have. That's not easy at all. Sometimes it changes. Things will happen. There'll be papers published. There'll be results released by other companies. It's a dynamic process. What might not be the most important today may suddenly become super important tomorrow on the basis of various results. It makes it exciting, though. Yeah. I talked about the innovation within the team. That's genuine. That's not just me BSing at an AGM. It genuinely is one of the most creative, innovative teams I've ever come across.
And that makes it fun. It makes it enjoyable. It makes it exciting. And we had a three-day strategy session offsite. And the number of ideas we went through was quite extraordinary. So, well, with that, I think we've come to the end of the questions that people want to ask in public. So I thank you very much indeed to all of you for giving up a big chunk of a very, very nice day out there to come and meet with us and talk about your company. So I can declare the meeting closed. Everyone's sticking around. So you've got plenty of time to grab people, grab a sandwich, have a cup of tea or whatever. But again, thank you very, very much indeed for taking your time and showing interest in what your company's doing. As I said, we're always very, very grateful for that.
Thank you.